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OpenTrials
Completed

NCT Number: NCT00527995

Acute Effects of Sildenafil on Endothelial Function in People With Diabetes

This is a double-blind, placebo-controlled, cross-over trial using a single dose of 100 mg sildenafil or placebo in 40 subjects with T2DM without known cardiovascular disease. Effects on haemodynamic parameters, flow mediated dilatation (FMD) in brachial artery, cardiovascular autonomic function tests, and spontaneous baroreflex sensitivity (BRS) were investigated.

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Key information

Conditions

Type 2 Diabetes Mellitus Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Endothelial Dysfunction Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

35 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

German Diabetes Center

Düsseldorf, North Rhine-Westphalia, 40225, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • age 35-70
  • type 2 diabetes mellitus
  • impotence
  • with and without hypertension, hypercholesteremia

Exclusion criteria

  • patients with history of cardiovascular and malignant disease,
  • advanced nephropathy (creatinine≥2.2mg/dl)
  • hepatopathy (liver enzymes higher than the double of normal values)
  • patients taking nitrates
  • CHF: NYHA > II
  • Stable angina: CCS > II

Treatment and study plan

Sildenafil

Drug

Orally administered, Sildenafil 100mg, unique administration

Other names: Viagra

Primary outcomes

  1. Improvement of flow mediated dilatation of the brachial artery following a single dose of 100mg Sildenafil.

    Time frame: 60 minutes

Secondary outcomes

  1. Change in hemodynamics and cardiovascular parasympathetic and sympathetic nerve function using time domain and frequency domain indexes of heart rate variability (HRV) and baroreflex sensitivity (BRS) following a single dose of 100mg Sildenafil.

    Time frame: 60 minutes

Sponsors and collaborators

Lead sponsor

Ruhr University of Bochum

Other

Registry information

Official study title

Acute Effects of Sildenafil on Flow Mediated Dilatation and Cardiovascular Autonomic Nerve Function in Type 2 Diabetic Patients

Important dates

Study start
2001
Study completion
2003
First posted
Sep 11, 2007
Registry last updated
Sep 11, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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